Mask

ABSTRACT

A mask is disclosed that has a gas outlet which is quiet and provides for a diffused outlet flow of gases. The outlet is preferably a slot formed between a hollow body and cover over said hollow body. The mask also preferably extends and seals under a user&#39;s chin in use.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

Any and all applications for which a foreign or domestic priority claimis identified in the Application Data Sheet as filed with the presentapplication are hereby incorporated by reference under 37 CFR 1.57.

The present application is a continuation of U.S. application Ser. No.16/010,827, filed Jun. 18, 2018, which is a continuation of U.S.application Ser. No. 15/789,268, filed Oct. 20, 2017, now U.S. Pat. No.10,034,994, which is a continuation application of U.S. application Ser.No. 15/156,073, filed May 16, 2016, now U.S. Pat. No. 10,004,865, whichis a continuation application of U.S. application Ser. No. 14/832,271,filed Aug. 21, 2015, now U.S. Pat. No. 9,339,621, which is acontinuation application of U.S. application Ser. No. 14/270,200, filedMay 5, 2014, now U.S. Pat. No. 9,144,655, which is a continuationapplication of U.S. application Ser. No. 10/570,226, filed Nov. 1, 2006,now U.S. Pat. No. 8,714,157, which is a national phase filing of PCTApplication No. PCT/NZ2004/000194, filed Aug. 20, 2004, which claims apriority benefit to New Zealand Patent Application No. 528029, filedSep. 3, 2003, each of which is incorporated herein by reference in itsentirety.

BACKGROUND OF THE INVENTION Field of the Invention

This invention relates to the delivery of respiratory gases, and inparticular to patient interfaces for providing gases to patientsrequiring respiratory therapy.

Summary of the Prior Art

In the art of respiration devices, there are well known a variety ofrespiratory masks which cover the nose and/or mouth of a human user inorder to provide a continuous seal around the nasal and/or oral areas ofthe face such that gas may be provided at positive pressure within themask for consumption by the user. The uses for such masks range fromhigh altitude breathing (i.e., aviation applications) to mining and firefighting applications, to various medical diagnostic and therapeuticapplications.

One requisite of such respiratory devices has been that they provide aneffective seal against the user's face to prevent leakage of the gasbeing supplied. Commonly, in prior mask configurations, a goodmask-to-face seal has been attained in many instances only withconsiderable discomfort for the user. This problem is most crucial inthose applications, especially medical applications, which require theuser to wear such a mask continuously for hours or perhaps even days. Insuch situations, the user will not tolerate the mask for long durationsand optimum therapeutic or diagnostic objectives thus will not beachieved, or will be achieved with great difficulty and considerableuser discomfort.

Where such masks as those used above are used in respiratory therapy, inparticular treatment of obstructive sleep apnea (OSA) using ContinuousPositive Airway Pressure (CPAP) therapy, there is generally provided inthe art a vent for washout of the bias flow or expired gases to theatmosphere. Such a vent may be provided for example, as part of themask, or in the case of some respirators where a further conduit carriesthe expiratory gases, at the respirator. The washout of gas from themask is essential to ensure that carbon dioxide build up does not occurover the range of flow rates. In the typical flow rates in CPAPtreatment, usually between 4 cm H₂O to 20 cm H₂O, prior art attempts atsuch vents have resulted in excessive noise causing irritation to theuser and concentrated flows of gases irritating any bed partners.

Various approaches have been developed in the prior art to attempt toreduce the noise by using slots to disperse the escaping gases when CPAPtherapy is provided. For example, U.S. Pat. Nos. 6,460,539 and3,890,966. However, these prior art methods are not entirelysatisfactory in eliminating the extra noise created by a vent at themask.

SUMMARY OF THE INVENTION

It is an object of the present invention to attempt to provide a maskwhich goes some way to overcoming the abovementioned disadvantages inthe prior art or which will at least provide the industry with a usefulchoice.

Accordingly in a first aspect the invention consists in a device fordelivering a supply of gases to a user comprising:

a mask, in use in fluid communication with said supply of gases andsupplying said gases to said user,

at least one outlet member integrated with or attached to said mask,

wherein the boundary between said outlet member and said mask forms atleast one narrow outlet vent that in use passes a substantial portion ofthe expired gases of said user,

said outlet vent comprises a slot formed in said mask and a coverextending over said slot and attached to said mask, such that theseparation between said mask and said cover increases to the edge ofsaid cover in order to diffuse said exhaled gases.

Preferably said outlet member is removable.

Preferably said at least one outlet vent is a substantially long taperedslot.

Alternately said at least one outlet vent is a substantially circularhole.

Preferably said at least one outlet vent extends between the top andbottom of said mask.

Preferably said mask is a nasal mask.

Preferably said mask is a full face mask.

In a further aspect the present invention consists in a CPAP system fordelivering gases to a user including a pressurised source of gases,transport means in fluid communication with said pressurised sourceadapted to convey said gases, and a mask in fluid communication withsaid transport means in use delivering said gases to said user,

said mask including:

at least one outlet member integrated with or attached to said mask,

wherein the boundary between said outlet member and said mask forms atleast one long narrow tapered slot that in use passes a substantialportion of the expired gases of said user,

wherein said outlet vent comprises a slot formed in said mask and acover extending over the slot and attached to the mask, such that theseparation between the mask and the cover increases to the edge of thecover in order to diffuse said exhaled gases.

Preferably said outlet member is removable.

In a further aspect the present invention consists in an outlet memberfor a gases delivery mask,

said mask including at least one said outlet member, the boundarybetween said outlet member and said mask forms at least one narrowoutlet vent that in use passes a substantial portion of expired gasesfrom a user,

wherein the outlet member comprises a cover extending over a slot in themask and attached to the mask, such that the separation between the maskand the cover increases to the edge of the cover in order to diffuse theexhaled gases.

BRIEF DESCRIPTION OF THE DRAWINGS

The preferred form of the present invention will now be described withreference to the accompanying drawings.

FIG. 1 is a block diagram of a humidified continuous positive airwaypressure (CPAP system) as might be used in conjunction with the mask ofthe present invention.

FIG. 2 is a perspective exploded view of the mask and outlet member ofthe preferred embodiment of the mask of the present invention.

FIG. 3 is a perspective view of the mask of the present invention.

FIG. 4 is a side cross section of the mask and outlet member of thepresent invention.

FIG. 5 is a close up view of detail A of FIG. 4 of the mask of thepresent invention.

FIG. 6 is a perspective view of a first alternative form of the mask ofthe present invention.

FIG. 7 is an exploded perspective view of the mask of FIG. 6.

FIG. 8 is a perspective view of a second alternative form of the mask ofthe present invention.

FIG. 9 is a side view of the mask of FIG. 8.

FIG. 10 is a cross-section through BB of the mask on FIG. 8.

FIG. 11 is a close-up cross-section of a first form of the outlet memberof the mask of FIG. 8, where the outlet member curves away from the maskbody.

FIG. 12 is a close-up cross-section of a second form of the outletmember for use with the mask of FIG. 8, where the outlet member extendsstraight out from the mask body.

FIG. 13 is a side view of the mask of FIG. 2, where the mask is shown tohave a cushion that rests in use against and users face.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention provides improvements in the field of CPAPtherapy. In particular to a mask with a gas outlet is described which isquieter and has a more diffused outlet flow. In addition the manufactureof the gas outlet on a mask is simpler; it does not suffer to the sameextent from excessive manufacturing faults. It will be appreciated thatthe mask as described in the preferred embodiment of the presentinvention can be used in respiratory care generally or with a ventilatorbut will now be described below with reference to use in a humidifiedCPAP system. It will also be appreciated that the outlet vent describedis equally applicable to all forms of patent interface. It will also beappreciated that the outlet vent described can be used with variousforms of mask, it is not limited to use with full face masks, but isdescribed below with reference to full face masks.

The full face mask of the present invention also has the added benefitof extending under the chin of the patient in use, and as such patientsdo not require a chin strap, as is the case with some prior art masks.

With reference to FIG. 1 a humidified Continuous Positive AirwayPressure (CPAP) system is shown in which a patient 1 is receivinghumidified and pressurised gases through a patient interface, forexample a full face mask 2 (as shown in FIG. 2) or other appropriatetypes of patient interfaces, such as nasal masks. The patient interface2 is connected to a humidified gases transportation pathway orinspiratory conduit 3. It should be understood that delivery systemscould also be VPAP (Variable Positive Airway Pressure) and BiPAP(Bi-level Positive Airway Pressure) or numerous other forms ofrespiratory therapy. Inspiratory conduit 3 is connected to the outlet 4of a humidification chamber 5 which contains a volume of water 6.Inspiratory conduit 3 may contain heating means or heater wires (notshown) which heat the walls of the conduit to reduce condensation ofhumidified gases within the conduit. Humidification chamber 6 ispreferably formed from a plastics material and may have a highly heatconductive base (for example an aluminium base) which is in directcontact with a heater plate 7 of humidifier 8. Humidifier 8 is providedwith control means or electronic controller 9 which may comprise amicroprocessor based controller executing computer software commandsstored in associated memory.

Controller 9 receives input from sources such as user input means ordial 10 through which a user of the device may, for example, set apredetermined required value (preset value) of humidity or temperatureof the gases supplied to patient 1. The controller may also receiveinput from other sources, for example temperature and/or flow velocitysensors 11 and 12 through connector 13 and heater plate temperaturesensor 14. In response to the user set humidity or temperature valueinput via dial 10 and the other inputs, controller 9 determines when (orto what level) to energise heater plate 7 to heat the water 6 withinhumidification chamber 5. As the volume of water 6 within humidificationchamber 5 is heated, water vapour begins to fill the volume of thechamber above the water's surface and is passed out of thehumidification chamber 5 outlet 4 with the flow of gases (for exampleair) provided from a gases supply means or blower 15 which enters thechamber through inlet 16. Exhaled gases from the patient's mouth exitthrough vents in the mask and are passed to ambient surroundings, asshown in FIG. 1.

Blower 15 is provided with variable pressure regulating means orvariable speed fan 21 which draws air or other gases through blowerinlet 17. The speed of variable speed fan 21 is controlled by electroniccontroller 18 (or alternatively the function of controller 18 couldcarried out by controller 9) in response to inputs from controller 9 anda user set predetermined required value (preset value) of pressure orfan speed via dial 19.

Referring to FIGS. 2 and 13 a patient interface that is a full face maskis shown in detail. The mask 2 includes a hollow body 30 and maskcushion 33. The mask cushion 33 resides within the hollow body 30 andprovides cushioning of the mask 2 or the patient's face. The hollow bodyand mask cushion are shown in FIGS. 1 and 13 as extending under thepatients chin, in particular, in the area indicated as 55. The extensionunder the chin of the cushion 33 provides a good seal and rendersunnecessary a chin strap.

The hollow body 30 has an integrally formed recess 31. The recess 31preferably extends longitudinally along and over the width of the maskbody 30 but may not extend the full width of the mask as shown in FIG.2. Further the recess 31 may not be a longitudinal recess but lateral orother orientation. An outlet member or insert 32 is fittable about or inthe recess. The insert 32 substantially covers the whole of the recess31. The recess 31 and insert 32 each have complimentary circularapertures 34, 35 that form an inspiratory inlet 36 when the insert 32 isplaced in the recess 30. The inlet 36 is capable of being connected tothe tubing that forms the inspiratory conduit 3 (as shown on FIG. 1).Gases, supplied to the inspiratory conduit 3 from the CPAP device andhumidifier, enter the mask through the apertures 34, 35 and the patientis able to breathe these gases. The mask 2 is positioned around the noseand mouth of the user 1 and headgear (not shown) may be secured aroundthe back of the head of the patient 1 to assist in the maintaining ofthe mask on the patient's face. The restraining force from the headgearon the hollow body 30 ensures enough compressive force on the maskcushion 33 to provide an effective seal against the patient's face.

The hollow body 30 and insert 32 are injection moulded in a relativelyinflexible material, for example, polycarbonate plastic. Such a materialwould provide the requisite rigidity for the mask as well as beingtransparent and a relatively good insulator.

Referring to FIG. 3, when the insert 32 is in placed on the mask shellor hollow body 30 in the recess 31 narrow slots 37, 38 are createdbetween the mask shell 30 and insert 32. These slots 37, 38 act asexpiratory vents for gases expired in use into the mask by the patientwearing the mask.

In some forms of the mask of the present invention the insert 32 isremovable, but in other forms the insert is welded in place to preventremoval.

The insert 32 and narrow slots or outlet vents 37, 38 will now bedescribed in more detail. Referring to FIGS. 2 to 5, the insert 32 iscurved to follow the contours of the mask shell 30 and has upper andlower sides 39, 40 that taper down towards the left and right sides 41,42. Two elongated recesses 53, 54 are formed on the insert's upper andlower sides 39, 40. The recesses 53, 54 are shown as being formed in themiddle section 43 of the insert 32 near to the inspiratory aperture 34and do not extend over the full length of the upper and lower sides 39,40. In other forms the recesses (that form the expiratory vents) mayextend along the full length of the upper and lower sides of the insert.Thus when the insert 32 attached or connected to the mask shell into therecess 31, formed at the boundary between the insert 32 and mask shell30 are narrow outlet vents 37, 38.

To provide support to the insert 32, within the recess a number of wallsare provided that the insert rests against. In particular, as shown inFIG. 2, a lower internal wall 48 having side walls 49, 50 extendingupwards from it is formed at the lower edge of the recess 31. The loweroutlet vent 37 is actually formed between the boundary of the lower wall48 and the lower side of the insert 32. Upper internal sideways walls51, 52 are also formed in the recess 31. These provide further supportand each of the side walls 49, 50, 51, 52 fit within slots (of whichonly two slots 53, 54 of the four slots is shown in FIG. 2.

The insert 32 may be permanently fixed in the mask shell 30 by gluing,ultrasonic welding or other appropriate fastening methods. In otherforms, and particularly that shown in FIG. 2, the insert 32 is removablefrom the mask shell 30 and is provided with clips 45, 46. The clips 45,46 are fastenable in apertures (of which only one side aperture 47 isshown in FIG. 2) at the sides of the mask body 30. The clips merely needto be pushed inwards by a user to disengage them from the apertures 47so that the insert 32 can be removed.

FIGS. 3 to 5 show the mask of the present invention in an in use formwhere the insert 32 is attached to the mask shell 30 and a conduit 3that is inserted and held within the inspiratory inlet 36 and apertureformed in the insert 32 and through the mask shell 30. The conduit 3 maybe connected to an elbow connector 44, which may also be capable ofswivelling within the aperture.

To ensure a proper seal around the outlet vents 37, 38 and between theinsert 32 and mask shell 30 a plastics gasket, for example, one made ofelastomer, such as silicon, may be provided between the insert 32 andmask shell 30. The gasket (not shown) would ensure sealing between theseparts and reduce the noise of gases exiting the vents 37, 38.

It will be appreciated that by providing expiratory vents in the mask ofthe present invention effectively allows for minimising of the noisegenerated by the outward flow of expiratory gases form the mask, as wellas reducing the noise level, the flow through the outlet vents is morediffused.

An alternative form of the mask of the present invention is shown inFIGS. 6 and 7. The mask 100 has a cushion 101, body or shell 102 and agases inlet 104 that receives gases from a conduit (for example conduit3 as described with reference to FIG. 1). The mask shell 102 has aplurality of small diameter holes 105 in it that are ideally alldirected away from the centre of the mask, i.e. diffusing or dispersingthe flow of air. The holes 105 are shown in FIGS. 6 and 7 as beingcircular but in other forms of the mask they may be otherwise shaped.Furthermore, the holes may be straight through the mask or have analternative section, for example they may be narrow nearer the innerside of the mask and broader in section nearer the outer side of themask shell 103. In order to be able to mould small enough holes 105 inthe mask shell 102, the mask shell is preferably split into two or moresections (for example, the three sections 106, 107, 108 as shown in FIG.7) although more or less sections could be provided in some forms of themask. The sections 106, 107, 108 are preferably joined together in anyof the following ways, snap-lock, friction press fit, gluing, welding orany other appropriate fastening mechanism.

This form of the mask of the present invention would have the advantagethat the plurality of holes 105 produces less noise but there isdifficulty in moulding the sections 106, 107, 108.

A further alternative form of the mask of the present invention isillustrated in FIGS. 8 to 12. The mask 200 is similar to that describedabove and has a hollow body 201 and a cushion (not shown). The mask 200is preferably a full face mask but may be a nasal mask or oronasal mask.The mask 200 has a gases inlet 202 that is capable of being connected toa conduit (such as inspiratory conduit 3, in FIG. 1) that supplies gasesto the mask from a humidifier and blower as described earlier. In usewhen a patient is wearing the mask 201 they breathe in the gasesentering the mask through the inlet 202 and exhale into the mask. Tovent exhaled gases an outlet vent and/or diffuser 203 is provided on theoutside of the mask hollow body 201. The outlet vent and/or diffuser 203has an outlet member or cover 205 that extends over a slot or pluralityof holes in the mask body 201.

This mask 200 has an alternative diffuser system where a narrow air gap208 is formed between the outlet member 205 and the body 201, such thatgases exhaled by the patient are forced through the air gap and diffusedas they move out into the ambient air. In particular, a slot 204 (orseries of holes, or any other means of allowing exhaled gases to exitthe hollow body 201) are formed in the hollow body 201 and the outletmember 205, in the form of a cover is fitted about the slit 204. Thecover 205 is substantially trapezoidal in shape and its bottom and sideedges are fixed to the hollow body 201 of the mask 200. The bottom edgeis substantially shorter in length than its top edges such that thewidth of the cover 203 increases from it's bottom to top edges. Thecover 205 may be permanently fixed to the mask body (for example, bybeing welded, clipped or glued to the mask body 201) or may be able tobe removed (for example, if the cover 205 was removably clipped to themask body 201).

Referring to FIGS. 9 and 10, the front face of the cover 205 extendsoutwards from the mask body 201 such that an angle α (see FIG. 10) isformed between the mask body 201 and the front fact 205. This angle α isrelatively low so that the gases exhaled by the patient that exit thegap 204 attach to the walls, in particular, the mask body wall 206 andthe inner cover wall 207. With the gradual expansion in the area insideof the cover 205 the velocity of the gases passing through the air gap208 reduces because the cross-sectional area of the gases flow increasesas it moves out of the outlet member 203.

Referring now to FIGS. 11 and 12, in the preferred form of the mask ofthe present invention, the cover 205 may extend outwards from the maskbody at a constant angle α, such as that shown in FIG. 11, so that thecover is substantially straight. In other forms of the cover (such asthat cover 209 shown in FIG. 12) could be curved, so that the angle βbetween the mask body 210 and cover 209 gradually increases. It must benoted that the angle β will not exceed a predetermined angle, forexample, it has been determined that angles greater than 20 degreesprovide less than ideal diffusing of the exhales gases.

What is claimed is:
 1. A patient interface for delivering a supply ofgases to a user, the patient interface comprising: a body having a frontside and a back side, the front side comprising an elongate recessextending across a width of the body, the body comprising an aperturepositioned within the elongate recess; a cushion coupled to a peripheryof the body and configured to contact a face of the user in use; anelongate insert configured to at least partly cover the front side ofthe body, the elongate insert coupled to the body and disposed in theelongate recess, the elongate insert constructed of a rigid material,wherein the elongate insert extends from a first side of the body to anopposite side of the body when the elongate insert is coupled to thebody; and an inlet defined through the elongate insert, wherein theinlet is aligned with the aperture to form an inspiratory inletconfigured to receive an inspiratory conduit for supplying the gases tothe patient interface.
 2. The patient interface of claim 1, furthercomprising an expiratory vent for gases expired into the patientinterface by the user.
 3. The patient interface of claim 1, wherein theinsert and the body are welded together.
 4. The patient interface ofclaim 1, wherein the elongate insert clips onto the body.
 5. The patientinterface of claim 1, wherein the insert is curved to follow contours ofthe body.
 6. An apparatus for delivering a supply of gases to a user,the apparatus comprising: a body having a front side and a back side,the body comprising: a recess on a front side of the body, the recesscomprising an internal wall; a circular aperture; a plurality of supportwalls extending from the internal wall; and an insert coupled to thebody and disposed in or about the recess, the insert comprising aninlet, the insert constructed of a rigid material, wherein the inlet isaligned with the circular aperture to form an inspiratory inletconfigured to receive an inspiratory conduit for supplying the gases tothe user; the plurality of support walls are configured to support theinsert, wherein the recess completely surrounds a circumference of thecircular aperture.
 7. The apparatus of claim 6, wherein the internalwall is a lower edge of the recess.
 8. The apparatus of claim 6, whereinthe internal wall is an upper edge of the recess.
 9. The apparatus ofclaim 6, wherein the insert is curved to follow contours of the body.10. The apparatus of claim 6, further comprising an elbow connector heldwithin the inlet.
 11. The apparatus of claim 6, wherein the insert andthe body are welded together.
 12. A mask system configured to providepositive air pressure therapy to a patient, the mask system comprising:a cushion configured to provide a seal against the patient's face; ahollow body coupled to the cushion, the hollow body comprising acircular aperture configured to receive a supply of air at positivepressure; and an insert configured to connect to the hollow body, theinsert constructed of a rigid material, the insert comprising: a frontwall and a rear wall, the rear wall configured to at least partly covera front side of the hollow body, at least one recess configured toaccommodate gases expired into the mask by the user; at least one clipextending rearwardly from the rear wall of the insert, the at least oneclip configured to engage the hollow body.
 13. The mask system of claim12, further comprising a swiveling elbow connector configured to swivelrelative to the circular aperture.
 14. The mask system of claim 12,wherein the insert comprises a circular inlet complimentary with thecircular aperture.
 15. The mask system of claim 12, wherein the hollowbody comprises at least one support wall, the insert configured to restagainst the at least one support wall.
 16. The mask system of claim 12,wherein the hollow body comprises a recessed surface configured toaccommodate the insert.
 17. The mask system of claim 12, wherein theinsert is removably connected to the hollow body.
 18. The mask system ofclaim 12, wherein the insert is configured to be removed from the hollowbody by pushing the at least one clip inward.
 19. The mask system ofclaim 12, wherein the at least one clip comprises a plurality of clips.